Catalog Number B1120-040 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that during device preparation and prior to use the armada 35 balloon dilatation catheter was being flushed when the hub was noted to be cracked.The device was not used; there was no reported patient involvement.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).Report source - a user facility report was not received.Evaluation summary: abbott vascular (av) analyzed the returned device and confirmed the reported leak and cracked hub.A review of the complaint history identified no other similar incidents from this lot.Av conducted root cause analysis and determined the most probable cause was related to the manufacture of the device.The issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.
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Search Alerts/Recalls
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